Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions

Opioid-use Disorder Clinical Trial

— MOTHER DYAD  

Official title:

Medically-supervised Withdrawal vs. Agonist Maintenance in the Treatment of Pregnant Women With Opioid Use Disorder: Maternal, Fetal, and Neonatal Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049799
• Other study ID #: STUDY00000166
• Secondary ID: R01DA047867
• Status: Completed
• Start date: August 8, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and neonatal outcomes. Outcomes will be assessed during pregnancy, at birth and for 12 months postpartum. This study has the potential to impact health service policy and practices in terms of the treatment options of pregnant women with opioid use disorder.

Description:

Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

Inclusion Criteria:

• Be ages 18 to 41, inclusive

• Have a single fetus pregnancy between 6-30 weeks estimated gestational age

• Willing to participate in the study

Exclusion Criteria:

• Non-English speaking

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Neonatal Opioid Withdrawal Syndrome
• Opioid Withdrawal
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance Withdrawal Syndrome
• Syndrome

Intervention

Other:
• Medically-supervised withdrawal
6-8 day withdrawal with buprenorphine/naloxone
• Opioid agonist treatment
Induction and maintenance with buprenorphine/naloxone

Behavioral:
• Comprehensive clinical care
Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening

Locations

Country	Name	City	State
United States	Mountain Area Health Education Center	Asheville	North Carolina
United States	University of Vermont	Burlington	Vermont
United States	UNC Chapel Hill Horizons	Chapel Hill	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (6)

Lead Sponsor	Collaborator
University of Vermont	Johns Hopkins University, Mountain Area Health Education Center, National Institute on Drug Abuse (NIDA), University of North Carolina, Chapel Hill, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of mothers who discontinued 1st treatment choice prior to delivery		Antepartum period
Primary	Proportion of mothers engaged in treatment at delivery	Behavior health treatment or medical treatment in past 21 days	Antepartum period
Primary	Proportion of mothers with illicit substance use at delivery	Positive vs. negative for any illicit substance in the urine	At delivery
Primary	Proportion of mother-child dyads with delivery complications	Yes vs. no code for the presence or absence of delivery complications such as uterine rupture, placental abruption, low birth weight, chorioamnionitis, and meconium staining	At delivery
Primary	Proportion of neonates receiving medication treatment for neonatal abstinence syndrome (NAS)	Yes vs. no	At hospital discharge, an average of 10 days after delivery
Primary	Total average amount of medication given to treat NAS	Morphine Equivalent Dose in mg	At hospital discharge, an average of 10 days after delivery
Primary	Total average length of neonatal hospital stay	Days	At hospital discharge, an average of 10 days after delivery